NICOTINE POLACRILEX- nicotine polacrilex gum, chewing 
Chain Drug Consortium, LLC

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Nicotine Polacrilex Gum 2 mg - 4 mg Coated Ice Mint

Drug Facts

Active ingredient (in each chewing piece) - 2 mg

Nicotine Polacrilex 2 mg (nicotine)

Active ingredient (in each chewing piece) - 4 mg

Nicotine Polacrilex 4 mg (nicotine)

Purpose

Stop smoking aid

Use

Warnings

If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

Keep out of reach of children and pets.

Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions - 2 mg

Weeks 1 to 6

Weeks 7 to 9

Weeks 10 to 12

1 piece every
1 to 2 hours

1 piece every
2 to 4 hours

1 piece every
4 to 8 hours

Directions - 4 mg

Weeks 1 to 6

Weeks 7 to 9

Weeks 10 to 12

1 piece every
1 to 2 hours

1 piece every
2 to 4 hours

1 piece every
4 to 8 hours

Other information - 2 mg

Other information - 4 mg

Inactive ingredients - 2 mg

acacia, acesulfame potassium, carnauba wax, flavors, gum base, hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, talc, titanium dioxide and xylitol.

Inactive ingredients - 4 mg

acacia, acesulfame potassium, carnauba wax, D&C yellow #10 aluminum lake, flavors, gum base, hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, talc, titanium dioxide and xylitol.

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal display panel 2mg

COMPARE TO THE ACTIVE INGREDIENT IN NICORETTE® GUM*

Sugar Free

Nicotine Polacrilex Gum USP 2 mg (nicotine)

STOP SMOKING AID

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN 30 MINUTES of waking, use Nicotine Polacrilex Gum USP, 4 mg.

COATED ICE MINT 2 mg

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivated to quit.

2. Use Enough - Chew at least 9 pieces of Nicotine Polacrilex Gum per day during the first six weeks.

3. Use Long Enough - Use Nicotine Gum for the full 12 weeks.

4. Use with a Support Program as directed in the enclosed User's Guide.

*This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare, L.P., distributor of Nicorette® Gum

BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN.

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

Package label 2 mg

Nicotine Polacrilex 2 mg (nicotine)

PREMIER VALUE Sugar Free Nicotine Gum Ice Mint Flavor

Principal display panel 4 mg

COMPARE TO THE ACTIVE INGREDIENT IN NICORETTE® GUM*

Sugar Free

Nicotine Polacrilex Gum USP, 4 mg (nicotine)

STOP SMOKING AID

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette MORE THAN  30 MINUTES after waking up, us Nicotine Polacrilex Gum USP, 2 mg

COATED ICE MINT 4 mg

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivated to quit.

2. Use Enough - Chew at least 9 pieces of Nicotine Polacrilex Gum per day during the first six weeks.

3. Use Long Enough - Use Nicotine Polacrilex Gum for the full 12 weeks.

4. Use with a Support Program as directed in the enclosed User's Guide.

*This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare, L.P., distributor of Nicorette® Gum.

BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEAL ARE OPEN OR TORN.

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

Package label 4 mg

Nicotine Polacrilex 4 mg (nicotine)

PREMIER VALUE Sugar Free Nicotine Ice Mint Flavor

NICOTINE POLACRILEX 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-292
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
ColorwhiteScoreno score
ShapeSQUARESize14mm
FlavorMINT (coated ice mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-292-44100 in 1 CARTON10/01/2017
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20479410/01/2017
NICOTINE POLACRILEX 
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-293
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
ColoryellowScoreno score
ShapeSQUARESize14mm
FlavorMINT (coated ice mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-293-44100 in 1 CARTON10/01/2017
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20483310/01/2017
Labeler - Chain Drug Consortium, LLC (101668460)

Revised: 11/2022
Document Id: 62d1099c-200b-4ac2-8e11-3d6ce46845a5
Set id: 9c115cd5-1952-4f1e-8e88-27f2c528e91f
Version: 7
Effective Time: 20221121
 
Chain Drug Consortium, LLC